CTRI/2021/11/037714尚未招募2 期
Phase II Non-Randomized Open Clinical Evaluation Of Siddha Medicine Guru Parpam For The Management Of Santhu Vatham (Polyarthritis)
Government SIddha Medical College1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2021年10月11日最近更新:
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Primary Outcome is mainly assessed by reduction in clinical symptoms measured by universal pain assessment scale
研究概览
简要总结
This is a Single non randomised open clinical trial to study the safety and efficacy of siddha trial drug Guru Parpam.The Trial is given 488mg twicea day for 48 days. Clinical trial conducted after conducting Pre-clinical toxicity study. The trial drug Guru parpam is mentioned in Sarabendra vaidiya rathnavali .During the trial all the study related data will be recorded and documented. After the completion of the trial all the data will be analysed statistically.
研究设计
- 研究类型
- Interventional
- 分配方式
- Not Applicable
- 盲法
- Not Applicable
入排标准
- 年龄范围
- 20.00 Year(s) 至 60.00 Year(s)（—）
- 性别
- All
入选标准
- •Joint pain Swelling Stiffness Tenderness Restricted movements Post viral arthritis Seronegative RA.
排除标准
- •Pregnancy and lactating women Rheumatic fever Rheumatoid arthritis.
结局指标
主要结局
Primary Outcome is mainly assessed by reduction in clinical symptoms measured by universal pain assessment scale
时间窗: 48 days
次要结局
- Secondary Outcome is mainly assessed by comparing the safety parameters before and after treatment(48 days)
研究者
研究点 (1)
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